Clinical study design for devices, Investigational Device Exemptions, Good Clinical Practice, study endpoints, and basic biostatistics.
Not every device needs a clinical trial — many 510(k) clearances rely entirely on bench and biocompatibility data against a predicate — but this module covers exactly when clinical evidence becomes necessary: when bench and animal data cannot answer the safety or effectiveness question that actually matters, such as a novel algorithm's real-world diagnostic accuracy or a permanent implant's long-term biological response.
It then builds the Investigational Device Exemption framework that authorizes a clinical study before a device is cleared or approved, Good Clinical Practice and ISO 14155's conduct requirements, how primary, secondary, safety, and effectiveness endpoints are chosen, and enough basic biostatistics — sample size, p-values, confidence intervals — to read and design a device clinical study responsibly, setting up Module 12's postmarket evidence coverage.